Chronic Ankle InstabilitySSICCNCT06269471
On the ICC's Path: a Prevalence Study
An observational study of Chronic Ankle Instability, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability. However, there are no studies informing of the prevalence of chronic ankle instability in trail running. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Trail Running racers who have participated in at least one Trail Running competition in their lifetime. Subjects will be recruited via an online questionnaire distributed through various French Trail Running organizations and social networks.
Who may be able to join
- Trail Running
- Ultra Trail Running runners
- Having participated́ in at least one Trail Running or Ultra Trail Running competition in their lifetime.
- Over 18 years of age (adult participants)
Who cannot join
- Adults protected under Article L1121-8 of the French Public Health Code
- Minors
- Adults unable to give consent
Trial locations and contacts
1 site in 1 country.
France1 site
University Grenoble Alpes
Grenoble, 38000
Leo Druart, leo.druart@univ-grenoble-alpes.fr
Audrey Milon
About this study
Official title: Prevalence and Impact of Chronic Ankle Instability in Trailers : an Epidemiological Study on French Trails
The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.
However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France.
Read the detailed description
Trail Running Trail running (TRu) is a running sport that abounds in creativity in the composition of its courses. It is the most popular sport in off-road running. The International Trail Running Association (ITRA), TRu's international governing body since 2013, with the International Association of Ultrarunners (IAU), manages and develops ultra-distance races under the patronage of the International Association of Athletics Federations (IAAF). They defines TRu as running in a natural environment including mountains, deserts, forests, coastal areas, jungles or rainforests, grassy or arid plains over a variety of different terrains with a minimum of paved or asphalt roads (not exceeding 20 to 25% of the total course). TRu can be practiced in competitions open to all, in semi-self-sufficiency or in self-sufficiency. The latter takes place with respect for sporting ethics, fairness, solidarity and the environment. This sport differs from Ultra Trail Running in terms of distance. Indeed, any race longer than a marathon, i.e. 42.195km, qualifies as an Ultra. On the other hand, there is no difference or restriction as to the altitude difference covered.
According to the Fédération Française d'Athlétisme (FFA), there are now over 800,000 TRu enthusiasts in France and 20 million worldwide. For more than ten years, this outdoor sport, whose popularity grew with the Covid-19 pandemic, has been growing at an annual rate of around 12% worldwide. The year 2022, for example, saw a massive expansion, with more Trail Running events than road races recorded in France for the first time (3035 versus 2706). This represents an average of almost 418 events scheduled every weekend for TRu enthusiasts.
Ankle sprains Among the most common sports pathologies, lateral ankle sprains are the most common, well ahead of muscle injuries and tendinopathies. In 2015 in France, there were nearly 6,000 cases of ankle sprains every day, corresponding to more than 1.2 million euros in just 24 hours. In other words, 70% of the population has already suffered a sprain in the course of their life. These figures reflect a real public health problem.
Ankle sprain is described as a "condition resulting from distortion beyond physiological limits during forced, abrupt movement of the hindfoot without permanent bony displacement". Four different types of ankle sprains are usually reported, including lateral talocrural sprain (the most common), medial talocrural sprain (extremely rare), subtalar sprain and anterior sprain. In 95% of cases, the injury involves the lateral collateral ligament plane. The patho-mechanics of this injury correspond to a sequence of forced inversion associated with pure varus, internal rotation, forced plantar flexion, and forced eversion.
Chronic ankle instability Ankle sprains have the highest recurrence rate of all lower-limb injuries, and in 40% of cases develop into chronic instability. Following a first episode, 70% of people will suffer a recurrence. In fact, this risk doubles the following year. Poor management of ankle sprains can have significant consequences for the joint and its function.
According to the new model updated by Hertel, chronic ankle instability (CAI) is defined by 8 elements. These include the sprain and associated primary tissue damage, environmental factors, personal factors, patho-mechanical impairments, perceptual and sensory impairments, behavioral and motor impairments, the interactions between each element and the spectrum of clinical outcomes. A patient with CHF, however, does not systematically possess each of these impairments.
Copers patients The mere presence of an ankle sprain does not determine the evolution of this injury into chronic instability. Indeed, so-called "Copers" patients have suffered a lateral ankle sprain but have not developed a sensation of instability or sprain recurrence after 12 months. The explanations for this recovery are multiple and specific to each patient.
The Cumberland Ankle Instability Tool Several diagnostic tools can be used to assess CCI. The International Ankle Consortium recommends the use of the Cumberland Ankle Instability Tool as a validation questionnaire specific to chronic ankle instability. The CAIT consists of 9 items in a 30-point format to measure the severity of functional ankle instability (FAI). This validated self-questionnaire distinguishes between people with CAI and those without (p<0.001), with a threshold score ≤ 23 points for the French version and ≤ 25 for the English version. Significant correlations were observed between the CAIT, the LEFS and the VAS, other validated questionnaires, in addition to excellent test-retest reliability. The translation of this self-questionnaire involves different threshold scores (≤23 and ≤25) respectively validated.
Data on ankle sprain and TRu PubMed lists over 2,234 results for the keyword "ankle chronic instability". A search for the keywords "ankle chronic instability" AND "sport", reveals 503 corresponding studies, i.e. 4 times fewer. A search of "ankle chronic instability" AND "running", reveals almost 48 results. Despite this, the new combination of "ankle chronic instability" AND "trail running" yields no published studies. The terms "outdoor", "mountain", "ultra trail running" or "hiking" also produced no results.
Given the increase in practice and the lack of data, further research is paramount knowledge about chronic ankle instability in TRu. There are good reasons to believe that ankle injuries are frequent in this sport and that they can have significant consequences.
Objectives As a first step, investigators will study the prevalence of CCI among TRu practitioners. Prevalence, which corresponds to the number of cases of a disease in a population at a given time, encompassing both new and old cases, would enable us to assess the relevance or otherwise of conducting further, more in-depth studies on the subject. Investigators would also like to clarify the circumstances and factors associated with the injury, in order to establish a true picture of this pathology in France.
Issues In summary, the number of runners is constantly increasing, and TRu seems to be a high-risk activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.
However, there are no studies on the prevalence of chronic ankle instability in trail running. The aim of this study is, therefore, to take stock of chronic ankle instability in trail running in France.
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic Ankle Instability, Trail Running, Ultra Trail Running, Ankle Sprain, Prevalence
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trailers | Group of major trail runners who have already taken part in at least one trail running competition in their lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic ankle instability in trailers
Number of cases among all respondents with a Cumberland Ankle Instability Tool Score ≤ 23 points for the French version end ≤ 25 points for the English version. (validated questionnaire)
Measured: Time 0
Secondary outcomes (20)
Socio-demographic data (1/4)
Average ages among the 3 study populations (in years)
Measured: Time 0
Socio-demographic data (2/4)
Proportion of sex ratios among 3 study populations
Measured: Time 0
Socio-demographic data (3/4)
Proportion of majority training grounds among 3 study populations
Measured: Time 0
Socio-demographic data (4/4)
Proportion of practice statuses among the 3 study populations
Measured: Time 0
Trail running and prevalence reports (1/11)
Proportion of training club members among the 3 populations studied
Measured: Time 0
Trail running and prevalence reports (2/11)
Average years of practice among the 3 populations studied (in years)
Measured: Time 0
Trail running and prevalence reports (3/11)
Average training hours per week among the 3 populations studied (in hours)
Measured: Time 0
Trail running and prevalence reports (4/11)
Average distances covered in training per week among the 3 populations studied (in kilometers)
Measured: Time 0
Trail running and prevalence reports (5/11)
Proportion of competitions per year among the 3 populations studied
Measured: Time 0
Trail running and prevalence reports (6/11)
Average distances covered in competition among the 3 study populations (in kilometers)
Measured: Time 0
Trail running and prevalence reports (7/11)
Average times spent in competition among the 3 populations studied (in hours)
Measured: Time 0
Trail running and prevalence reports (8/11)
Proportions of sprain occurrence times during annual programming among Copers and ICC populations
Measured: Time 0
Trail running and prevalence reports (9/11)
Proportion of sprain occurrence times during sessions among Copers and ICC populations
Measured: Time 0
Trail running and prevalence reports (10/11)
Proportions of sprain occurrence times according to pitch inclination variability in the Copers and ICC populations.
Measured: Time 0
Trail running and prevalence reports (11/11)
Proportion of sprain occurrence times according to variability of terrain characteristics in the Copers and ICC populations.
Measured: Time 0
Associated pathologies (1/2)
Proportions of the presence or absence of musculoskeletal disorders recorded over the past 12 months among the 3 populations studied.
Measured: Time 0
Associated pathologies (2/2)
Proportions and body chart of pathologies among participants having recorded a musculoskeletal disorder in the last 12 months within the 3 populations studied
Measured: Time 0
Medical care (1/3)
Proportion of participants having had or using physiotherapy in the Copers and ICC populations.
Measured: Time 0
Medical care (2/3)
Proportions of medical devices used among Copers and ICC populations
Measured: Time 0
Medical care (3/3)
Proportion of different sprain-related impacts among Copers and ICC populations
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leo Druart, PhD, Principal investigator, University Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269471
- Sponsor's protocol ID
- 2023-A02039-36
- Acronym
- SSICC
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Chronic Ankle Instability in Trailers : an Epidemiological Study on French Trails
- ClinicalTrials.gov ID
- NCT06269471
- Acronym / sponsor ID
- SSICC / 2023-A02039-36
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic Ankle Instability, Trail Running, Ultra Trail Running, Ankle Sprain, Prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.
However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France.
Detailed description
Trail Running Trail running (TRu) is a running sport that abounds in creativity in the composition of its courses. It is the most popular sport in off-road running. The International Trail Running Association (ITRA), TRu's international governing body since 2013, with the International Association of Ultrarunners (IAU), manages and develops ultra-distance races under the patronage of the International Association of Athletics Federations (IAAF). They defines TRu as running in a natural environment including mountains, deserts, forests, coastal areas, jungles or rainforests, grassy or arid plains over a variety of different terrains with a minimum of paved or asphalt roads (not exceeding 20 to 25% of the total course). TRu can be practiced in competitions open to all, in semi-self-sufficiency or in self-sufficiency. The latter takes place with respect for sporting ethics, fairness, solidarity and the environment. This sport differs from Ultra Trail Running in terms of distance. Indeed, any race longer than a marathon, i.e. 42.195km, qualifies as an Ultra. On the other hand, there is no difference or restriction as to the altitude difference covered.
According to the Fédération Française d'Athlétisme (FFA), there are now over 800,000 TRu enthusiasts in France and 20 million worldwide. For more than ten years, this outdoor sport, whose popularity grew with the Covid-19 pandemic, has been growing at an annual rate of around 12% worldwide. The year 2022, for example, saw a massive expansion, with more Trail Running events than road races recorded in France for the first time (3035 versus 2706). This represents an average of almost 418 events scheduled every weekend for TRu enthusiasts.
Ankle sprains Among the most common sports pathologies, lateral ankle sprains are the most common, well ahead of muscle injuries and tendinopathies. In 2015 in France, there were nearly 6,000 cases of ankle sprains every day, corresponding to more than 1.2 million euros in just 24 hours. In other words, 70% of the population has already suffered a sprain in the course of their life. These figures reflect a real public health problem.
Ankle sprain is described as a "condition resulting from distortion beyond physiological limits during forced, abrupt movement of the hindfoot without permanent bony displacement". Four different types of ankle sprains are usually reported, including lateral talocrural sprain (the most common), medial talocrural sprain (extremely rare), subtalar sprain and anterior sprain. In 95% of cases, the injury involves the lateral collateral ligament plane. The patho-mechanics of this injury correspond to a sequence of forced inversion associated with pure varus, internal rotation, forced plantar flexion, and forced eversion.
Chronic ankle instability Ankle sprains have the highest recurrence rate of all lower-limb injuries, and in 40% of cases develop into chronic instability. Following a first episode, 70% of people will suffer a recurrence. In fact, this risk doubles the following year. Poor management of ankle sprains can have significant consequences for the joint and its function.
According to the new model updated by Hertel, chronic ankle instability (CAI) is defined by 8 elements. These include the sprain and associated primary tissue damage, environmental factors, personal factors, patho-mechanical impairments, perceptual and sensory impairments, behavioral and motor impairments, the interactions between each element and the spectrum of clinical outcomes. A patient with CHF, however, does not systematically possess each of these impairments.
Copers patients The mere presence of an ankle sprain does not determine the evolution of this injury into chronic instability. Indeed, so-called "Copers" patients have suffered a lateral ankle sprain but have not developed a sensation of instability or sprain recurrence after 12 months. The explanations for this recovery are multiple and specific to each patient.
The Cumberland Ankle Instability Tool Several diagnostic tools can be used to assess CCI. The International Ankle Consortium recommends the use of the Cumberland Ankle Instability Tool as a validation questionnaire specific to chronic ankle instability. The CAIT consists of 9 items in a 30-point format to measure the severity of functional ankle instability (FAI). This validated self-questionnaire distinguishes between people with CAI and those without (p<0.001), with a threshold score ≤ 23 points for the French version and ≤ 25 for the English version. Significant correlations were observed between the CAIT, the LEFS and the VAS, other validated questionnaires, in addition to excellent test-retest reliability. The translation of this self-questionnaire involves different threshold scores (≤23 and ≤25) respectively validated.
Data on ankle sprain and TRu PubMed lists over 2,234 results for the keyword "ankle chronic instability". A search for the keywords "ankle chronic instability" AND "sport", reveals 503 corresponding studies, i.e. 4 times fewer. A search of "ankle chronic instability" AND "running", reveals almost 48 results. Despite this, the new combination of "ankle chronic instability" AND "trail running" yields no published studies. The terms "outdoor", "mountain", "ultra trail running" or "hiking" also produced no results.
Given the increase in practice and the lack of data, further research is paramount knowledge about chronic ankle instability in TRu. There are good reasons to believe that ankle injuries are frequent in this sport and that they can have significant consequences.
Objectives As a first step, investigators will study the prevalence of CCI among TRu practitioners. Prevalence, which corresponds to the number of cases of a disease in a population at a given time, encompassing both new and old cases, would enable us to assess the relevance or otherwise of conducting further, more in-depth studies on the subject. Investigators would also like to clarify the circumstances and factors associated with the injury, in order to establish a true picture of this pathology in France.
Issues In summary, the number of runners is constantly increasing, and TRu seems to be a high-risk activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.
However, there are no studies on the prevalence of chronic ankle instability in trail running. The aim of this study is, therefore, to take stock of chronic ankle instability in trail running in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trailers | – | –Group of major trail runners who have already taken part in at least one trail running competition in their lives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Trail Running racers who have participated in at least one Trail Running competition in their lifetime. Subjects will be recruited via an online questionnaire distributed through various French Trail Running organizations and social networks.
Key inclusion criteria (4 listed)
- Trail Running
- Ultra Trail Running runners
- Having participated́ in at least one Trail Running or Ultra Trail Running competition in their lifetime.
- Over 18 years of age (adult participants)
Key exclusion criteria (3 listed)
- Adults protected under Article L1121-8 of the French Public Health Code
- Minors
- Adults unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of chronic ankle instability in trailers
Time frame: Time 0
Number of cases among all respondents with a Cumberland Ankle Instability Tool Score ≤ 23 points for the French version end ≤ 25 points for the English version. (validated questionnaire)
20 secondary outcomes
Socio-demographic data (1/4)
Time frame: Time 0
Socio-demographic data (2/4)
Time frame: Time 0
Socio-demographic data (3/4)
Time frame: Time 0
Socio-demographic data (4/4)
Time frame: Time 0
Trail running and prevalence reports (1/11)
Time frame: Time 0
Trail running and prevalence reports (2/11)
Time frame: Time 0
Trail running and prevalence reports (3/11)
Time frame: Time 0
Trail running and prevalence reports (4/11)
Time frame: Time 0
Trail running and prevalence reports (5/11)
Time frame: Time 0
Trail running and prevalence reports (6/11)
Time frame: Time 0
Trail running and prevalence reports (7/11)
Time frame: Time 0
Trail running and prevalence reports (8/11)
Time frame: Time 0
Trail running and prevalence reports (9/11)
Time frame: Time 0
Trail running and prevalence reports (10/11)
Time frame: Time 0
Trail running and prevalence reports (11/11)
Time frame: Time 0
Associated pathologies (1/2)
Time frame: Time 0
Associated pathologies (2/2)
Time frame: Time 0
Medical care (1/3)
Time frame: Time 0
Medical care (2/3)
Time frame: Time 0
Medical care (3/3)
Time frame: Time 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo Druart, PhD principal investigator
University Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aïda Mandzo (+33 (0)4 76 76 68 16, amandzo@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of chronic ankle instability in trailers (time frame: Time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.